Protocol for a prospective, hospital-based registry of pregnant women with SARS-CoV-2 infection in India: PregCovid Registry study

Abstract

IntroductionPregnant women are at increased risk of contracting COVID-19 due to several factors and therefore require special attention. However, the consequences of the COVID-19 pandemic on pregnant women and their newborns remain uncharted. The PregCovid registry aims to document the impact of SARS-CoV-2 infection on pregnant, postpartum women and their newborns. The aim of the registry is also to determine mother-to-child transmission of SARS-CoV-2 infection in India.Methods and analysisPregCovid is a hospital-based registry for capturing information of pregnant, postpartum women with COVID-19 and their newborns in India. Medical case records of pregnant and postpartum women with a laboratory-confirmed diagnosis of COVID-19 will be captured in real-time using an online electronic patient record software. The data analysis will be carried out for symptoms, the severity of COVID-19, pregnancy complications, maternal morbidity and mortality, neonatal complications, mother-to-child transmission, etc. Data analysis will be carried out for different waves of the COVID-19 pandemic for rapid response and developing strategies well in advance to manage pregnant women infected with SARS-CoV-2. The evidence generated from the registry will be regularly shared with the appropriate authorities for policy decisions. Thus, the registry data may be useful for planning the strategies for better management of pregnant women with COVID-19.Ethics and disseminationThe study has been approved by the Institutional Ethics Committees of all the participating study sites under the Medical Education and Drugs Department, Government of Maharashtra, Topiwala National Medical College & BYL Nair Charitable Hospital, Mumbai and ICMR-National Institute for Research in Reproductive and Child Health, Mumbai, India. The results from this study will be disseminated with local, state, and national health authorities, collaborators and the general population on the study website (https://pregcovid.com) as well as dissemination through scientific meetings and publications.Trial registration numberCTRI/2020/05/025423.

Outcomes in neonates born to mothers with COVID-19 during the second wave in India

“…1). The details on the data collection, quality controls, and study protocol are described elsewhere [8]. Maternal outcomes from the 19 study sites in Maharashtra state during the first wave of COVID-19 (March 2020 to January 2021) were reported previously [3].…”

Clinical presentation, pregnancy complications, and outcomes of pregnant women with COVID‐19 during the Omicron‐dominant third wave in Mumbai, India

“…The hospital admission policy 6 was uniform during all three waves of the COVID‐19 pandemic period. The data were captured as per the standardized data collection methods of the PregCovid registry 7 . A total of 2058 pregnant and postpartum women with COVID‐19 were admitted during the first, second, and third waves of COVID‐19 at NH.…”

“…The data were captured as per the standardized data collection methods of the PregCovid registry. 7 The study is registered with the Clinical Trial Registry of India (CTRI#2020-025423). A waiver of consent was granted by the institute ethics committees because the data were collected from the medical case records of the pregnant women with COVID-19.…”

Different impact of COVID‐19 on symptomatic pregnant and postpartum women in low‐income countries and low‐ and middle‐income countries

“…Immediately after the declaration of COVID‐19 pandemic, we launched the PregCovid registry (https://pregcovid.com/) through the network of 19 government medical colleges in Maharashtra, India for capturing information of pregnant, postpartum women with COVID‐19 and their newborns. The detailed information on study sites, inclusion and exclusion criteria of study participants, and data collection instruments was published elsewhere 7 . BYL Nair Charitable Hospital (NH), Mumbai, was the first dedicated COVID‐19 hospital in India providing maternal and newborn services to a population of more than 26 million in Mumbai Metropolitan Region, India.…”

“…The detailed information on study sites, inclusion and exclusion criteria of study participants, and data collection instruments was published elsewhere. 7 BYL Nair Charitable Hospital (NH), Mumbai, was the first dedicated COVID-19 hospital in India providing maternal and newborn services to a population of more than 26 million in Mumbai Metropolitan Region, India.…”